A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face (LESS)

Merz Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Sebum Production; Enlarged Pores

Treatments: Drug: NT 201; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05784363

M602011077

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of NT 201 injections in the treatment of enlarged pores and excessive sebum production in the face.

Full description

Eligible subjects will be randomized to one of the two treatment groups: NT 201 group and placebo in order to receive one session of injections with either NT 201 or placebo in the upper face (forehead and cheek area) on Day 1 and followed for about 90 days after treatment.

Enrollment: 31 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cheek pore size assessed as "large" by the investigator
• Oily skin on the forehead

Exclusion criteria

• Treatment with Botulinum toxin (BoNT) of any serotype in the face within the last 12 months
• Facial cosmetic procedure (e.g., chemical peel, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, ultrasound treatment, tattooing of eyebrows) within the last 12 months
• Treatment with any dermal filler in the face within the last 12 months
• Any previous insertion of permanent material in the face, including permanent dermal fillers (e.g., silicone, polymethyl methacrylate)
• Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

NT 201

Experimental group

Description:

Single NT 201 injection treatment.

Treatment:

Drug: NT 201

Placebo

Placebo Comparator group

Description:

Single placebo injection treatment.

Treatment:

Drug: Placebo